OtherEuropean Union
EU Clinical Trials Regulation (CTR 536/2014)
Regulation (EU) No 536/2014 (the Clinical Trials Regulation, CTR) harmonises the authorisation and conduct of clinical trials on medicinal products for human use across the EU/EEA. It repealed Directive 2001/20/EC and came into application on 31 January 2022 following the go-live of the Clinical Trials Information System (CTIS), with mandatory CTIS use from 31 January 2023 (new trials) and full transition by 31 January 2025 (legacy 2001/20/EC trials).
Domains
CTR - Start, End and Safety Reporting (Ch VI-VII)
CTR - Subject Protection and Informed Consent (Ch V)
CTR - Conduct, Manufacturing and Labelling (Ch VIII-X)
CTR - General Provisions (Ch I)
CTR - CTIS, Cooperation and Final Provisions (Ch XIV-XIX)
Compare EU Clinical Trials Regulation (CTR 536/2014)
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EU Clinical Trials Regulation (CTR 536/2014) by Industry
EU Clinical Trials Regulation (CTR 536/2014) for Healthcare→EU Clinical Trials Regulation (CTR 536/2014) for Financial Services→EU Clinical Trials Regulation (CTR 536/2014) for Technology→EU Clinical Trials Regulation (CTR 536/2014) for Government→EU Clinical Trials Regulation (CTR 536/2014) for Manufacturing→EU Clinical Trials Regulation (CTR 536/2014) for Energy→EU Clinical Trials Regulation (CTR 536/2014) for Retail→EU Clinical Trials Regulation (CTR 536/2014) for Education→
EU Clinical Trials Regulation (CTR 536/2014) by Role
EU Clinical Trials Regulation (CTR 536/2014) for CISOs→EU Clinical Trials Regulation (CTR 536/2014) for Compliance Officers→EU Clinical Trials Regulation (CTR 536/2014) for Risk Managers→EU Clinical Trials Regulation (CTR 536/2014) for IT Directors→EU Clinical Trials Regulation (CTR 536/2014) for DPOs→EU Clinical Trials Regulation (CTR 536/2014) for Auditors→
Frequently Asked Questions
What is EU Clinical Trials Regulation?
Regulation (EU) No 536/2014 (the Clinical Trials Regulation, CTR) harmonises the authorisation and conduct of clinical trials on medicinal products for human use across the EU/EEA. It repealed Directive 2001/20/EC and came into application on 31 January 2022 following the go-live of the Clinical Trials Information System (CTIS), with mandatory CTIS use from 31 January 2023 (new trials) and full transition by 31 January 2025 (legacy 2001/20/EC trials).
How many controls does EU Clinical Trials Regulation have?
EU Clinical Trials Regulation contains 30 controls organized across 8 domains.
Where does EU Clinical Trials Regulation apply?
EU Clinical Trials Regulation is applicable in European Union. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.
What frameworks does EU Clinical Trials Regulation map to?
EU Clinical Trials Regulation has control-to-control mappings with 4 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.
How do I get started with EU Clinical Trials Regulation compliance?
Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.
How ready are you for EU Clinical Trials Regulation (CTR 536/2014)?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.